NCT06096298

Brief Summary

Vitamin B12 is naturally present in animal products, but it could be added to plant-based products through fermentation using the Propionibacterium freudenreichii bacterium. This study aims to investigate the absorption of vitamin B12 synthesized by Propionibacterium freudenreichii from products made with fermented faba bean. The study products are wheat breads of which 30 % of the dry weight has been replaced with fermented faba bean flour. One of the study breads contains vitamin B12 produced by P. freudenreichii bacteria, and the other bread (control bread) is fermented using L. brevis bacteria (does not produce vitamin B12). The participants will eat the study bread for two consecutive days during the study weeks, with a washout period of 12 days. Fasting blood samples are collected on day 1 before administration of the first dose of vitamin B12 and on day 3. Nutrient intake and food consumption will be analyzed from 3-day food records at the baseline and on the bread eating days. The study is carried out in a double-blinded crossover setting.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 17, 2023

Last Update Submit

October 23, 2023

Conditions

Vitamin B12 Absorption

Keywords

cobalaminholotranscobalaminvitamin B12absorptionpropionibacterium freudenreichiifermented faba bean

Outcome Measures

Primary Outcomes (2)

  • Vitamin B12 bound to transcobalamin II (holoTc)

    Changes in serum holotranscobalamin concentrations after intake of vitamin B12

    2 days

  • Total B12

    Changes in serum total B12 concentrations after intake of vitamin B12

    2 days

Secondary Outcomes (1)

  • The intensity of gastrointestinal symptoms measured by a visual analogue scale

    4 weeks

Study Arms (3)

Vitamin B12 bread

ACTIVE COMPARATOR

Daily dose of bread containing B12 (15 µg of vitamin B12/d) and placebo tablet (0 µg of vitamin B12/d) for 2 consecutive days.

Other: Vitamin B12 bread

Positive control

ACTIVE COMPARATOR

Daily dose of control bread (0 µg of vitamin B12/d and B12 tablet (15 µg of vitamin B12/d) for 2 consecutive days.

Other: Control bread

Negative control

PLACEBO COMPARATOR

Daily dose of control bread (0 µg of vitamin B12/d and placebo tablet (0 µg of vitamin B12/d) for 2 consecutive days.

Other: Control bread

Interventions

Vitamin B12 breadOTHER

Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour containing vitamin B12 produced by P. freudenreichii bacteria.

Vitamin B12 bread
Control breadOTHER

Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour.

Negative controlPositive control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Body mass index between 18.5 and 35 kg/m2

You may not qualify if:

  • Food allergies against ingredients in foods supplemented in the study
  • pregnancy and/or breastfeeding
  • Regular use of food supplements containg B12
  • Blood donation within 3 months
  • Alcohol consumption more than 24 measures per week
  • Smoking, using snuff
  • Iron, B12 or folate deficiency
  • Anemia
  • small intestinal bacterial overgrowth (SIBO)
  • Gastritis
  • Helicobacter pylori infection
  • Acid reflux
  • Chron's disease
  • Celiac disease
  • Pancreatitis
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Anne-Maria Pajari, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Maria Pajari, PhD

CONTACT

+358294158203anne-maria.pajari@helsinki.fi

Maj Lundberg, MSc

CONTACT

+358504315431maj.lundberg@helsinki.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The study is double-masked - neither the researchers or the participants know which bread they are eating.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

October 1, 2023

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

The data collected is confidential and cannot be shared.